# 010 - "Don't Make Assumptions" with David Simoens

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2021-12-08
- Length: 1h 13m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/010---Dont-Make-Assumptions-with-David-Simoens-e1bdev8

## Summary

David Simoens, COO of cGMP Consulting Group, explains how a risk-based approach can streamline commissioning, qualification, and validation (C&Q) in pharmaceutical manufacturing. He details the transition from traditional, repetitive testing to leveraging data from Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) through rigorous User Requirement Specifications (URS) and risk assessments. Simoens highlights common pitfalls, such as poorly written 70-page URS documents and inadequate debugging at the vendor site, which lead to significant project delays and cost overruns. He emphasizes the importance of using tools like FMEA and ISPE guidelines to identify critical aspects early, ensuring that testing is performed once and leveraged through to Performance Qualification (PQ).

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=1) Introduction: David Simoens and cGMP Consulting Group
- [2:43](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=163) Simoens' Career Path: From Biochemistry to Pharma Consulting
- [5:20](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=320) The Dreaded P&ID Walkdowns and Schematic Accuracy
- [13:37](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=817) Defining Commissioning, Qualification, and Validation
- [21:23](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=1283) The Critical Role of Risk Assessment and URS
- [32:16](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=1936) Vendor Selection, Bidding, and Functional Specifications
- [39:46](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=2386) Factory Acceptance Tests (FAT) and Debugging Challenges
- [55:25](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=3325) Site Acceptance Tests (SAT) and Leveraging Testing
- [1:04:40](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens#t=3880) Growing cGMP Consulting and Leadership Lessons

## Topics

- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

companies scaling up

## Mentioned

- cGMP Consulting Group (company)
- ISPE (other)
- ASTM E2500 (other)
- PDA (other)
- ICH (other)

## Related episodes from other shows

- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (Global Medical Device Podcast)
- [#326 CSA vs. CSV: Modern Validation for Modern MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech) (Global Medical Device Podcast)
- [#360: Is It Possible to "Buy" a QMS?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms) (Global Medical Device Podcast)
- [Implementing an eQMS after Switching from Paper](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.